Cao Huijuan, Yang Guoyan, Wang Yuyi, Liu Jian Ping, Smith Caroline A, Luo Hui, Liu Yueming
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China, 100029.
Cochrane Database Syst Rev. 2015 Jan 19;1(1):CD009436. doi: 10.1002/14651858.CD009436.pub2.
Acne is a chronic skin disease characterised by inflamed spots and blackheads on the face, neck, back, and chest. Cysts and scarring can also occur, especially in more severe disease. People with acne often turn to complementary and alternative medicine (CAM), such as herbal medicine, acupuncture, and dietary modifications, because of their concerns about the adverse effects of conventional medicines. However, evidence for CAM therapies has not been systematically assessed.
To assess the effects and safety of any complementary therapies in people with acne vulgaris.
We searched the following databases from inception up to 22 January 2014: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL; 2014,Issue 1), MEDLINE (from 1946), Embase (from 1974), PsycINFO (from 1806), AMED (from 1985), CINAHL (from 1981), Scopus (from 1966), and a number of other databases listed in the Methods section of the review. The Cochrane CAM Field Specialised Register was searched up to May 2014. We also searched five trials registers and checked the reference lists of articles for further references to relevant trials.
We included parallel-group randomised controlled trials (or the first phase data of randomised cross-over trials) of any kind of CAM, compared with no treatment, placebo, or other active therapies, in people with a diagnosis of acne vulgaris.
Three authors collected data from each included trial and evaluated the methodological quality independently. They resolved disagreements by discussion and, as needed, arbitration by another author.
We included 35 studies, with a total of 3227 participants. We evaluated the majority as having unclear risk of selection, attrition, reporting, detection, and other biases. Because of the clinical heterogeneity between trials and the incomplete data reporting, we could only include four trials in two meta-analyses, with two trials in each meta-analysis. The categories of CAM included herbal medicine, acupuncture, cupping therapy, diet, purified bee venom (PBV), and tea tree oil. A pharmaceutical company funded one trial; the other trials did not report their funding sources.Our main primary outcome was 'Improvement of clinical signs assessed through skin lesion counts', which we have reported as 'Change in inflammatory and non-inflammatory lesion counts', 'Change of total skin lesion counts', 'Skin lesion scores', and 'Change of acne severity score'. For 'Change in inflammatory and non-inflammatory lesion counts', we combined 2 studies that compared a low- with a high-glycaemic-load diet (LGLD, HGLD) at 12 weeks and found no clear evidence of a difference between the groups in change in non-inflammatory lesion counts (mean difference (MD) -3.89, 95% confidence interval (CI) -10.07 to 2.29, P = 0.10, 75 participants, 2 trials, low quality of evidence). However, although data from 1 of these 2 trials showed benefit of LGLD for reducing inflammatory lesions (MD -7.60, 95% CI -13.52 to -1.68, 43 participants, 1 trial) and total skin lesion counts (MD -8.10, 95% CI -14.89 to -1.31, 43 participants, 1 trial) for people with acne vulgaris, data regarding inflammatory and total lesion counts from the other study were incomplete and unusable in synthesis.Data from a single trial showed potential benefit of tea tree oil compared with placebo in improving total skin lesion counts (MD -7.53, 95% CI -10.40 to -4.66, 60 participants, 1 trial, low quality of evidence) and acne severity scores (MD -5.75, 95% CI -9.51 to -1.99, 60 participants, 1 trial). Another trial showed pollen bee venom to be better than control in reducing numbers of skin lesions (MD -1.17, 95% CI -2.06 to -0.28, 12 participants, 1 trial).Results from the other 31 trials showed inconsistent effects in terms of whether acupuncture, herbal medicine, or wet-cupping therapy were superior to controls in increasing remission or reducing skin lesions.Twenty-six of the 35 included studies reported adverse effects; they did not report any severe adverse events, but specific included trials reported mild adverse effects from herbal medicines, wet-cupping therapy, and tea tree oil gel.Thirty trials measured two of our secondary outcomes, which we combined and expressed as 'Number of participants with remission'. We were able to combine 2 studies (low quality of evidence), which compared Ziyin Qinggan Xiaocuo Granule and the antibiotic, minocycline (100 mg daily) (worst case = risk ratio (RR) 0.49, 95% CI 0.09 to 2.53, 2 trials, 206 participants at 4 weeks; best case = RR 2.82, 95% CI 0.82 to 9.06, 2 trials, 206 participants at 4 weeks), but there was no clear evidence of a difference between the groups.None of the included studies assessed 'Psychosocial function'.Two studies assessed 'Quality of life', and significant differences in favour of the complementary therapy were found in both of them on 'feelings of self-worth' (MD 1.51, 95% CI 0.88 to 2.14, P < 0.00001, 1 trial, 70 participants; MD 1.26, 95% CI 0.20 to 2.32, 1 trial, 46 participants) and emotional functionality (MD 2.20, 95% CI 1.75 to 2.65, P < 0.00001, 1 trial, 70 participants; MD 0.93, 95% CI 0.17 to 1.69, 1 trial, 46 participants).Because of limitations and concerns about the quality of the included studies, we could not draw a robust conclusion for consistency, size, and direction of outcome effects in this review.
AUTHORS' CONCLUSIONS: There is some low-quality evidence from single trials that LGLD, tea tree oil, and bee venom may reduce total skin lesions in acne vulgaris, but there is a lack of evidence from the current review to support the use of other CAMs, such as herbal medicine, acupuncture, or wet-cupping therapy, for the treatment of this condition. There is a potential for adverse effects from herbal medicines; however, future studies need to assess the safety of all of these CAM therapies. Methodological and reporting quality limitations in the included studies weakened any evidence. Future studies should be designed to ensure low risk of bias and meet current reporting standards for clinical trials.
痤疮是一种慢性皮肤病,其特征为面部、颈部、背部和胸部出现炎症性斑点和黑头。囊肿和疤痕也可能出现,尤其是在病情较为严重时。由于担心传统药物的不良反应,痤疮患者常求助于补充和替代医学(CAM),如草药、针灸和饮食调整。然而,CAM疗法的证据尚未得到系统评估。
评估任何补充疗法对寻常痤疮患者的疗效和安全性。
我们检索了以下数据库,从数据库创建至2014年1月22日:Cochrane皮肤小组专业注册库、Cochrane对照试验中心注册库(CENTRAL;2014年第1期)、MEDLINE(从1946年起)、Embase(从1974年起)、PsycINFO(从1806年起)、AMED(从1985年起)、CINAHL(从1981年起)、Scopus(从1966年起)以及综述方法部分列出的其他一些数据库。检索Cochrane补充和替代医学领域专业注册库至2014年5月。我们还检索了五个试验注册库,并检查了文章的参考文献列表以获取更多相关试验的参考文献。
我们纳入了任何类型CAM的平行组随机对照试验(或随机交叉试验的第一阶段数据),将其与未治疗、安慰剂或其他活性疗法进行比较,受试对象为诊断为寻常痤疮的患者。
三位作者从每项纳入试验中收集数据,并独立评估方法学质量。他们通过讨论解决分歧,必要时由另一位作者进行仲裁。
我们纳入了35项研究,共有3227名参与者。我们评估大多数研究在选择、失访、报告、检测和其他偏倚方面存在不明风险。由于试验之间的临床异质性和数据报告不完整,我们只能在两项荟萃分析中纳入四项试验,每项荟萃分析两项试验。CAM的类别包括草药、针灸、拔罐疗法、饮食、纯蜂毒(PBV)和茶树油。一项试验由一家制药公司资助;其他试验未报告其资金来源。我们的主要主要结局是“通过皮肤病变计数评估的临床体征改善”,我们将其报告为“炎症性和非炎症性病变计数的变化”、“总皮肤病变计数的变化”、“皮肤病变评分”和“痤疮严重程度评分的变化”。对于“炎症性和非炎症性病变计数的变化”,我们合并了两项在12周时比较低血糖负荷饮食(LGLD)和高血糖负荷饮食(HGLD)的研究,发现两组在非炎症性病变计数变化方面没有明显差异的证据(平均差(MD)-3.89,95%置信区间(CI)-10.07至2.29,P = 0.10,75名参与者,2项试验,低质量证据)。然而,尽管这两项试验中的一项数据显示LGLD对减少寻常痤疮患者的炎症性病变(MD -7.60,95% CI -13.52至-1.68,43名参与者,1项试验)和总皮肤病变计数(MD -8.10,95% CI -14.89至-1.31,43名参与者,1项试验)有好处,但另一项研究中关于炎症性和总病变计数的数据不完整,无法用于综合分析。一项试验的数据显示,与安慰剂相比,茶树油在改善总皮肤病变计数(MD -7.53,95% CI -10.40至-4.66,60名参与者,1项试验,低质量证据)和痤疮严重程度评分(MD -5.75,95% CI -9.51至-1.99,60名参与者,1项试验)方面可能有好处。另一项试验显示花粉蜂毒在减少皮肤病变数量方面优于对照组(MD -1.17,95% CI -2.06至-0.28,12名参与者,1项试验)。其他31项试验的结果显示,在针灸、草药或湿拔罐疗法在提高缓解率或减少皮肤病变方面是否优于对照组方面,效果不一致。35项纳入研究中的26项报告了不良反应;他们没有报告任何严重不良事件,但具体纳入试验报告了草药、湿拔罐疗法和茶树油凝胶的轻度不良反应。30项试验测量了我们的两个次要结局,我们将其合并并表示为“缓解参与者数量”。我们能够合并两项研究(低质量证据),比较了滋阴清肝消痤颗粒和抗生素米诺环素(每日100毫克)(最差情况 = 风险比(RR)0.49,95% CI 0.09至2.53,2项试验,4周时206名参与者;最佳情况 = RR 2.82,95% CI 0.82至9.06,2项试验,4周时206名参与者),但两组之间没有明显差异的证据。纳入研究中没有一项评估“心理社会功能”。两项研究评估了“生活质量”,在两项研究中均发现补充疗法在“自我价值感”(MD 1.51,95% CI 0.88至2.14,P < 0.00001,1项试验,70名参与者;MD 1.26,95% CI 0.20至2.32,1项试验,46名参与者)和情绪功能(MD 2.20,95% CI 1.75至2.65,P < 0.00001,1项试验,70名参与者;MD 0.93,95% CI 0.17至1.69,1项试验,46名参与者)方面有显著差异。由于纳入研究的局限性和对其质量的担忧,我们无法就本综述中结局效应的一致性、大小和方向得出有力结论。
来自单项试验的一些低质量证据表明,LGLD、茶树油和蜂毒可能会减少寻常痤疮的总皮肤病变,但本综述缺乏证据支持使用其他CAM,如草药、针灸或湿拔罐疗法来治疗这种疾病。草药有产生不良反应的可能性;然而,未来的研究需要评估所有这些CAM疗法的安全性。纳入研究中的方法学和报告质量限制削弱了任何证据。未来的研究应设计为确保低偏倚风险并符合当前临床试验的报告标准。